BRUSSELS (dpa-AFX) - AbbVie (ABBV) announced Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP recommended the approval of upadacitinib (RINVOQ) for the treatment of adults with active non-radiographic axial spondyloarthritis or nr-axSpA.
The European Union decision is expected in the third quarter of 2022.
The CHMP positive opinion is based on results from the Phase 3 SELECT-AXIS 2 study showing upadacitinib (RINVOQ 15 mg, once daily) met the primary endpoint of ASAS40 response at week 14 versus placebo.
The recommendation is for the treatment of active nr-axSpA in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein or CRP and/or magnetic resonance imaging or MRI, who have responded inadequately to nonsteroidal anti-inflammatory drugs or NSAIDs.
nr-axSpA is part of the axial spondyloarthritis or axSpA spectrum and causes inflammation in the spine, leading to back pain and stiffness.
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which will review it and issue a Commission decision that will be valid in all member states of the EU, as well as Iceland, Liechtenstein, Northern Ireland and Norway.
Upadacitinib is currently approved for use in the EU in patients with moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe atopic dermatitis.
The use of upadacitinib in nr-axSpA is not approved in the U.S. or EU. Its efficacy and safety remain under review.
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